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A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
simvastatin (+) ezetimibe
Comparator: atorvastatin
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Metabolic Disorder

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement
  • No history of diabetes and 100 <=LDL-C <=250 mg/dl

Exclusion Criteria:

  • Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months
  • Congestive heart failure defined by New York Heart Association (NYHA) class III or IV
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Uncontrolled hypertension
  • Unstable angina

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vytorin®

    atorvastatin

    Arm Description

    simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks

    atorvastatin 10 mg; tablet, once daily, 8 Weeks

    Outcomes

    Primary Outcome Measures

    Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.

    Secondary Outcome Measures

    Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
    Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).

    Full Information

    First Posted
    July 2, 2007
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00496730
    Brief Title
    A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
    Official Title
    A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2007 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    5. Study Description

    Brief Summary
    Prevalence of metabolic syndrome in korea is increasing. There is no clinical trial targeting on such increasing populations like metabolic syndrome patients with Vytorin® in korea. Therefore this trial will help evaluate the lipid lowering effect of Vytorin® in asian population with metabolic syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    Metabolic Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    256 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vytorin®
    Arm Type
    Experimental
    Arm Description
    simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
    Arm Title
    atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    atorvastatin 10 mg; tablet, once daily, 8 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    simvastatin (+) ezetimibe
    Other Intervention Name(s)
    MK0653A, Vytorin®
    Intervention Description
    simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: atorvastatin
    Other Intervention Name(s)
    Lipitor®
    Intervention Description
    atorvastatin 10 mg; tablet, once daily, 8 Weeks
    Primary Outcome Measure Information:
    Title
    Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
    Time Frame
    Baseline and 8 Weeks
    Secondary Outcome Measure Information:
    Title
    Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
    Description
    Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).
    Time Frame
    Baseline and 8 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.
    Time Frame
    Baseline and Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement No history of diabetes and 100 <=LDL-C <=250 mg/dl Exclusion Criteria: Myocardial Infarction, coronary artery bypass surgery, or angioplasty within 3 months Congestive heart failure defined by New York Heart Association (NYHA) class III or IV Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins Uncontrolled hypertension Unstable angina
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)

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